Surface electromyography (sEMG) may provide reliable biomarkers of contractile muscle fatigue (CMF) during exercise in chronic obstructive pulmonary disease (COPD). This study aimed to: 1) determine the test-retest reliability of amplitude- and frequency-based sEMG metrics recorded from the quadriceps muscle during a constant-work-rate cycling test (CWRT); 2) assess their criterion validity for detecting CMF against potentiated twitch force (TWp); and 3) explore associations between sEMG metrics and physiological outcomes. Adults with COPD referred for pulmonary rehabilitation performed two CWRTs to the limit of tolerance (Tlim) at 75%-80% of the individual peak workload, with physiological responses recorded. CMF was assessed by: 1) amplitude- (root mean square, RMS) and frequency-based sEMG metrics recorded from the right quadriceps, analyzed per pedal stroke and expressed as Z-score changes at Tlim relative to a fatigue-free baseline; and 2) the postexercise change in TWp of the right quadriceps. Relative and absolute test-retest reliability, and criterion validity of sEMG against TWp were assessed. Twenty-five participants completed the assessments. Among the sEMG metrics, only vastus lateralis RMS showed adequate relative reliability [intraclass correlation coefficient (95% CI) = 0.79 (0.74-0.85)] but a nonnegligible standard error of measurement of 0.58. Moreover, vastus lateralis RMS showed 86% sensitivity and specificity versus TWp in identifying CMF. An increase of ≥0.65 Z-scores identified the threshold for sEMG-based CMF. Changes in vastus lateralis RMS were moderately correlated with physiological responses at Tlim (P < 0.05). In conclusion, vastus lateralis RMS derived from sEMG can be used as a biomarker of CMF during cycling in individuals with COPD.NEW & NOTEWORTHY This study provides novel evidence that exercise-induced changes in the amplitude of the vastus lateralis surface electromyography signal during a standardized constant-work-rate cycling test can represent a reliable and valid biomarker of quadriceps contractile muscle fatigue in individuals with moderate-to-severe COPD.
BACKGROUND:Recent studies suggest that fast and deep inspirations against either low or high external loads may provide patients with weaning difficulties with a training stimulus during inspiratory muscle training (IMT). However, the relationship between external IMT load, reflected by changes in airway pressure swings (ΔPaw), and total inspiratory effort, measured by oesophageal pressure swings (ΔPes), remains unexplored. Additionally, the association between ΔPes, ΔPaw, and inspiratory muscle activations remains unclear. OBJECTIVES:The ai of this study was to compare ΔPes and ΔPaw and their relationship with inspiratory muscle activation in patients with weaning difficulties during different breathing conditions. METHODS:ΔPes and scalene, sternocleidomastoid, and parasternal intercostal muscles activation were recorded during the following conditions: 1) (proportional) pressure support ventilation; 2) unsupported spontaneous breathing; 3) low-load IMT (load: <10% maximal inspiratory pressure, PImax = 3 cmH2O) executed with slow and deep inspirations (low-load slow) and 4) low-load IMT (load: <10% maximal inspiratory pressure, PImax = 3 cmH2O) executed with fast deep inspirations (low-load fast); and 5) high-load IMT (load ∼ 30% PImax) executed with fast and deep inspirations. ΔPaw, end-inspiratory lung volume, and peak inspiratory flow were recorded during conditions 2-5. Variables were compared across conditions using mixed-model analysis. Spearman's rank correlations were calculated between inspiratory muscle activations and both ΔPes and ΔPaw. RESULTS:Five patients (age: 68 ± 1 y; 20% male; PImax: 37 ± 7 cmH2O [59 ± 23% predicted]; forced vital capacity: 0.66 ± 0.16 L [21 ± 6% predicted]) were included in the study. ΔPes values were 3-4 times larger than ΔPaw values during unsupported spontaneous breathing and IMT conditions. ΔPes, sternocleidomastoid activation, end-inspiratory lung volume, and peak inspiratory flow were larger during low-load fast IMT than during low-load slow IMT and unsupported spontaneous breathing but were similar between low-load fast and high-load IMTs. Inspiratory muscle activations correlated weakly to moderately with ΔPaw and moderately with ΔPes. CONCLUSIONS:In five patients with weaning difficulties, low-load fast IMT provided a training stimulus similar to high-load IMT. Both yielded significantly higher training stimulus than low-load slow IMT and unsupported spontaneous breathing. These results should be considered in future trials comparing IMT with sham conditions. CLINICAL TRIAL REGISTRATION NUMBERS:NCT03240263 and NCT04658498.
Background An accurate assessment of intermediate left main (LM) stenoses is crucial for revascularization decision-making. However, data on LM revascularization strategy according to instantaneous wave-free ratio (iFR) are limited. This study aimed to evaluate the safety of deferring LM revascularization according to iFR. Methods The PHYNAL study is a prospective, multicenter registry that included consecutive patients with intermediate LM stenosis who underwent coronary physiology assessment. Patients in whom the treatment strategy (revascularization versus deferral) was based on the iFR cutoff of 0.89 were considered for the current subanalysis. The primary endpoint was major adverse cardiac events (MACE), a composite outcome including all-cause death, non-fatal myocardial infarction (MI), and target lesion revascularization (TLR). Secondary endpoints were cardiac death and each component of the primary endpoint. Results The study population consisted of 240 patients: 188 in the deferred and 52 in the revascularized groups. At a median follow-up of 24 months (IQR: 21 to 25 months), MACE occurred in 19 patients (10 %) in the deferred and 8 patients (16 %) in the revascularized groups (HR: 1.56; 95 % CI: 0.67 to 3.60; p = 0.30) with no significant difference. Rate of all-cause death was 5 % in the deferred versus 12 % in the revascularized groups (p = 0.1), cardiac death 3 % versus 8 % (p = 0.2), non-fatal MI 1 % versus 2 % (p = 0.4), and TLR 5 % versus 2 % (p = 0.5). Conclusions Deferring LM revascularization according to iFR is safe. Patients in whom LM revascularization is deferred based on iFR have comparable clinical outcomes to patients who undergo LM revascularization according to iFR.
Whether extra-diaphragmatic respiratory muscle output is altered in patients with unilateral diaphragm dysfunction (UDD) remains unclear. We compared respiratory pressures and muscle activity during symptom-limited cardiopulmonary exercise testing (CPET) in 10 patients with UDD and 10 matched controls. Ventilatory variables, dyspnea, and electromyography (EMG) of the diaphragm, scalene, sternocleidomastoid, and parasternal intercostals were assessed at iso-ventilation and peak ventilation. Compared to controls, patients with UDD showed lower peak workload and oxygen consumption (p < 0.029), with a 10% lower but not statistically different peak ventilation (p = 0.078). At peak, they were more likely to report high dyspnea (p = 0.050). EMG patterns were similar between groups at iso-ventilation (40 L/min). At peak, controls had greater diaphragm (p = 0.007) and parasternal intercostal (p = 0.042) activity, while UDD patients showed earlier activation of scalene (p = 0.021) and sternocleidomastoid (p = 0.049), and greater expiratory muscle recruitment (p = 0.004). These findings suggest that patients with UDD rely on earlier and increased activation of extra-diaphragmatic and expiratory muscles to compensate for reduced diaphragm function during intense exercise. Targeting these compensatory mechanisms may be beneficial in managing diaphragm dysfunction.
BACKGROUND Drug-eluting stents (DESs) with controlled antiproliferative drug release reduce restenosis risk, but durable polymers can delay healing and inhibit reendothelializati on. The Firehawk biodegradable polymer sirolimuseluting stent (BP-SES) has a fully biodegradable sirolimus-containing polymer coating localized to recessed abluminal grooves on the stent surface and delivers roughly one-third the drug dose of other DESs. OBJECTIVES We report the primary results of the TARGET-IV NA (Firehawk Rapamycin Target Eluting Coronary Stent North American Trial) randomized controlled trial comparing clinical outcomes with BP-SES vs currently used second- generation DESs. METHODS The TARGET-IV NA study was a prospective, multicenter, single-blind, 1:1 randomized noninferiority trial comparing the BP-SES with control in North America and Europe among patients undergoing percutaneous coronary intervention for chronic or acute coronary syndromes. The primary endpoint was target lesion failure (TLF) at 12 months (composite of cardiac death, target vessel-related myocardial infarction, or ischemia-driven target lesion revascularization). The primary analysis (intention-to-treat) tested noninferiority of BP-SES vs control using an absolute margin of 3.85% and 1-sided a of 0.025. Noninferiority-powered secondary endpoints were tested in an optical coherence tomography substudy (endpoint: mean neointimal hyperplasia thickness) and an angiography substudy (endpoint: in-stent late lumen loss). RESULTS A total of 1,720 patients (mean age 66 years; 74% male) with 2,159 lesions were randomly allocated to receive either BP-SES (860 patients, 1,057 lesions) or control second-generation DES (860 patients, 1,084 lesions). A total of 61% of patients presented with stable coronary disease, 32% had unstable angina, and 7% had non-ST-segment elevation myocardial infarction (NSTEMI) or recent ST-segment elevation myocardial infarction. The rate of TLF with BP-SES was noninferior to control at 12 months (3.4% vs 3.3%, absolute risk difference 0.13%, upper bound 97.5% CI: 2.03, Pnoninferiority < 0.0001). Cardiac death, myocardial infarction, and stent thrombosis rates were similar between groups. Angiographic follow-up was available in 104 patients (97.2% of those enrolled in the angiographic substudy) and 128 (94.1%) lesions. At 13 months, the powered secondary endpoint of mean in-stent late lumen loss was 0.149 f 0.263 mm for BP-SES and 0.327 f 0.463 mm for control (least squares mean difference:-0.178; 90% CI:-0.2943 to-0.0632; Pnoninferiority < 0.0001). The optical coherence tomography substudy included 37 patients (42 lesions) with no difference in mean neointimal hyperplasia thickness between groups at 13 months (Pnoninferiority = 0.01). CONCLUSIONS The biodegradable polymer sirolimus-eluting stent was noninferior to currently used second-generation DES with regard to TLF at 1 year. (FirehawkO Rapamycin Target Eluting Coronary Stent North American Trial; NCT04562532) (JACC. 2025;85:563-574) (c) 2025 Published by Elsevier on behalf of the American College of Cardiology Foundation.
Evaluating respiratory drive presents challenges due to the obtrusiveness and impracticality of current methods like functional magnetic resonance imaging (fMRI). Electromyography (EMG) offers a surrogate measure of respiratory drive to the muscles, allowing the determination of both the magnitude and timing of muscle activation. The magnitude reflects the level of muscle activation, while the timing indicates the onset and offset of muscle activity relative to specific events, such as inspiratory flow and activation of other muscles. These metrics are critical for understanding respiratory coordination and control, especially under varying loads or in the presence of respiratory pathophysiology. This study outlines a protocol for acquiring and analyzing respiratory muscle EMG signals in healthy adults and patients with respiratory health conditions. Ethical approval was obtained for the studies, which included participant preparation, electrode placement, signal acquisition, preprocessing, and postprocessing. Key steps involve cleaning the skin, locating muscles via palpation and ultrasound, and applying electrodes to minimize electrocardiography (ECG) contamination. Data is acquired at a high sampling rate and gain, with synchronized ECG and respiratory flow recordings. Preprocessing includes filtering and transforming the EMG signal, while postprocessing involves calculating onset and offset differences relative to the inspiratory flow. Representative data from a healthy male participant performing incremental inspiratory threshold loading (ITL) illustrate the protocol's application. Results showed earlier activation and prolonged duration of extradiaphragmatic muscles under higher loads, correlating with increased EMG magnitude. This protocol facilitates a detailed assessment of respiratory muscle activation, providing insights into both normal and pathophysiologic motor control strategies.
ImportanceThe differences between the use of fractional flow reserve (FFR) or instantaneous wave-free ratio (iFR) in the long term are unknown.ObjectiveTo compare long-term outcomes of iFR- and FFR-based strategies to guide revascularization.Design, Setting, and ParticipantsThe DEFINE-FLAIR multicenter study randomized patients with coronary artery disease to use either iFR or FFR as a pressure index to guide revascularization. Patients from 5 continents with coronary artery disease and angiographically intermediate severity stenoses who underwent hemodynamic interrogation with pressure wires were included. These data were analyzed from March, 13, 2014, through April, 27, 2021.MAIN OUTCOME MEASURESFive-year major adverse cardiac events (MACE) (a composite of all-cause death, nonfatal myocardial infarction, and unplanned revascularization), as well as the individual components of the combined end point.ResultsAt 5 years of follow-up, no significant differences were found between the iFR (mean age [SD], 65.5 [10.8] years; 962 male [77.5%]) and FFR (mean age [SD], 65.2 [10.6] years; 929 male [74.3%]) groups in terms of MACE (21.1% vs 18.4%, respectively; hazard ratio [HR], 1.18; 95% CI, 0.99-1.42; P = .06). While all-cause death was higher among patients randomized to iFR, it was not driven by myocardial infarction (6.3% vs 6.2% in the FFR study arm; HR, 1.01; 95% CI, 0.74-1.38; P = .94) or unplanned revascularization (11.9% vs 12.2% in the FFR group; HR, 0.98; 95% CI, 0.78-1.23; P = .87). Furthermore, patients in whom revascularization was deferred on the basis of iFR or FFR had similar MACE in both study arms (17.9% in the iFR group vs 17.5% in the FFR group; HR, 1.03; 95% CI, 0.79-1.35; P = .80) with similar rates of the components of MACE, including all-cause death. On the contrary, in patients who underwent revascularization after physiologic interrogation, the incidence of MACE was higher in the iFR group (24.6%) compared with the FFR group (19.2%) (HR, 1.36; 95% CI, 1.07-1.72; P = .01).Conclusions and relevanceAt 5-year follow up, an iFR based–strategy was not statistically different than an FFR strategy to guide revascularization in terms of MACE, nonfatal myocardial infarction, and unplanned revascularization.Trial RegistrationClinicalTrials.gov Identifier: NCT02053038
Manual dexterity deficits impair the ability to effectively use touchscreen devices in people with Parkinson’s disease (PD). To examine the effects and feasibility of a home-based, unsupervised tablet-task training on task-specific performance in a randomized controlled trial and to determine which individuals are likely to benefit. Thirty-four PD patients were randomized and included into an experimental training (EXP, N = 16) and passive control group (CTL, N = 18). The EXP practiced a Swipe-Slide Pattern (SSP) task on a tablet (5x/week for 2 weeks) as fast and accurately as possible in single and dual task conditions. Performance on the SSP and an untrained mobile phone task (MPT) were tested before and after two weeks of training and after four weeks follow-up. SSP-Time (primary outcome), SSP-Accuracy ( https://clinicaltrials.gov/ : NTC05696197, retrospectively registered on January 13, 2023.
The aim of this study was to investigate the role of age and intellectual impairment (II) in decision-making in basketball. The current study investigated differences in decision making between equally well-trained adult basketball male players with intellectual impairment (players with II) (n = 93), adults without II (senior) (n = 44) and youth basketball players (under-14, n = 31; under-16, n = 25; under-18, n = 30). A computer test was developed composed by 20 photographs displaying various basketball game-situations, and participants had to decide as fast as possible what the player in ball possession should do: dribble, pass or shoot. Decision time and accuracy were recorded for every situation. Players with II had slower decision time (3.8 ± 1.8 s vs. 1.5 ± 0.5 s, p < 0.001) and less decision-making accuracy (15.7 ± 2.8 correct decisions vs. 17.9 ± 1.2 correct decisions, p < 0.001) compared to senior players without II. Discriminant analysis with speed and accuracy as independent variables classified 91.2% (CCA = 0.769) of the players correctly into their group: players with II or players without II. A Spearman correlation revealed that age correlated significantly (p < 0.001) with the number of correct decisions (rs = 0.269) and mean decision time (rs = −0.331). Our findings support that decision making in basketball develops with age and experience, but is significantly deteriorated in experienced adult players who have II. Decision-making should be considered as an important eligibility criterion to participate in competitive basketball events for male players with II.
OBJECTIVES:This study aimed to assess discordance between results of instantaneous wave-free ratio (iFR), fractional flow reserve (FFR), and intravascular ultrasound (IVUS) in intermediate left main coronary (LM) lesions, and its impact on clinical decision making and outcome. METHODS:We enrolled 250 patients with a 40%-80% LM stenosis in a prospective, multicenter registry. These patients underwent both iFR and FFR measurements. Of these, 86 underwent IVUS and assessment of the minimal lumen area (MLA), with a 6 mm2 cutoff for significance. RESULTS:Isolated LM disease was recognized in 95 patients (38.0%), while 155 patients (62.0%) had both LM disease and downstream disease. In 53.2% of iFR+ and 56.7% of FFR+ LM lesions, the measurement was positive in only one daughter vessel. iFR/FFR discordance occurred in 25.0% of patients with isolated LM disease and 36.2% of patients with concomitant downstream disease (P=.049). In patients with isolated LM disease, discordance was significantly more common in the left anterior descending artery and younger age was an independent predictor of iFR-/FFR+ discordance. iFR/MLA and FFR/MLA discordance occurred in 37.0% and 29.4%, respectively. Within 1 year of follow-up, major cardiac adverse events (MACE) occurred in 8.5% and 9.7% (P=.763) of patients whose LM lesion was deferred or revascularized, respectively. Discordance was not an independent predictor of MACE. CONCLUSIONS:Current methods of estimating LM lesion significance often yield discrepant findings, complicating therapeutic decision-making.
Background: In the prospective, multicentre, randomised TARGET All Comers study, percutaneous coro-nary intervention (PCI) with the FIREHAWK biodegradable-polymer sirolimus-eluting stent (BP-SES) was non-inferior to the durable-polymer everolimus-eluting stent (DP-EES) for the primary endpoint of target lesion failure (TLF) at 12 months. Aims: We aimed to report the final study outcomes at 5 years. Methods: Patients referred for PCI were randomised to receive either a BP-SES or DP-EES in a 1:1 ratio in 10 European countries. Randomisation was stratified by centre and ST-elevation myocardial infarction (STEMI) presentation, and clinical follow-up extended to 5 years. The primary endpoint was TLF (com-posite of cardiac death, target vessel myocardial infarction [MI], or ischaemia-driven target lesion revascu-larisation). Secondary endpoints included patient-oriented composite events (POCE; composite of all-cause death, all MI, or any revascularisation and its components). Results: From December 2015 to October 2016, 1,653 patients were randomly assigned to the BP-SES or DP-EES groups, of which 93.8% completed 5-year clinical follow-up or were deceased. At 5 years, TLF occurred in 17.1% of the BP-SES group and in 16.3% of the DP-EES group (p=0.68). POCE occurred in 34.0% of the BP-SES group and 32.7% of the DP-EES group (p=0.58). Revascularisation was the most common POCE, occurring in 19.3% of patients receiving BP-SES and 19.2% receiving DP-EES, of which less than one-third was ischaemia-driven target lesion-related. In the landmark analysis, there were no dif-ferences in the rates of TLF and POCE between groups from 1 to 5 years, and these results were consistent across all subgroups. Conclusions: In an all-comers population requiring stent implantation for myocardial ischaemia, the BP-SES was non-inferior to the DP-EES for the primary endpoint of TLF at 12 months, and results were sustained at 5 years, confirming the long-term safety and efficacy of the FIREHAWK BP-SES.
BACKGROUND. Recurrent in-stent restenosis (ISR) remains a serious problem. Optimal modification of the underlying mechanism during index percutaneous coronary intervention (PCI) is key to prevent ISR. Excimer laser coronary atherectomy (ELCA) has its own indications and is among others used in recurrent ISR in case of stent underexpansion and/or diffuse neointimal hyperplasia. We aimed to assess the long-term clinical outcomes of ELCA for the management of recurrent ISR. METHODS. A multicenter, retrospective observational study was conducted. Patients with recurrent ISR who were additionally treated with ELCA were included. The primary outcome was major adverse cardiac events (MACE) defined as a composite of cardiovascular death, myocardial infarction, stroke, target lesion revascularization at 12 months, and longer term. RESULTS. Between 2014 and 2022, 51 patients underwent PCI with the additional use ELCA for recurrent ISR. Primary outcome occurred in 6 patients (11.8%) at 12 months and in 12 patients (23.5%) at a median follow-up of 4 (1-6) years. Technical and procedural success were achieved in 92% and 90% of cases, respectively. Coronary perforation occurred in 2 patients as a result of distal wire perforation, but was not ELCArelated. There were no in -hospital MACE. CONCLUSIONS. ELCA appears to be a safe method with acceptable long-term results for the management of recurrent ISR.
Background Unilateral diaphragm dysfunction (UDD) is an underdiagnosed cause of dyspnoea. Inspiratory muscle training (IMT) is the only conservative treatment for UDD, but the mechanisms of improvement are unknown. We characterised the effects of IMT on dyspnoea, exercise tolerance and respiratory muscle function in people with UDD. Methods 15 people with UDD (73% male, 61±8 years) were randomised to 6 months of IMT (50% maximal inspiratory mouth pressure (PI,max), n=10) or sham training (10% PI,max, n=5) (30 breaths twice per day). UDD was confirmed by phrenic nerve stimulation and persisted throughout the training period. Symptoms were assessed by the transitional dyspnoea index (TDI) and exercise tolerance by constant-load cycle tests performed pre- and post-training. Oesophageal (Pes) and gastric (Pga) pressures were measured with a dual-balloon catheter. Electromyography (EMG) and oxygenation (near-infrared spectroscopy) of respiratory muscles were assessed continuously during exercise. Results The IMT group (from 45±6 to 62±23% PI,max) and sham group (no progression) completed 92 and 86% of prescribed sessions, respectively. PI,max, TDI scores and cycle endurance time improved significantly more after IMT versus sham (mean between-group differences: 28 (95% CI 13–28) cmH2O, 3.0 (95% CI 0.9–5.1) points and 6.0 (95% CI 0.4–11.5) min, respectively). During exercise at iso-time, Pes, Pga and EMG of the scalene muscles were reduced and the oxygen saturation indices of the scalene and abdominal muscles were higher post- versus pre-training only in the IMT group (all p<0.05). Conclusion The effects of IMT on dyspnoea and exercise tolerance in UDD were not mediated by an improvement in isolated diaphragm function, but may reflect improvements in strength, coordination and/or oxygenation of the extra-diaphragmatic respiratory muscles.
The evaluation of motion abilities is crucial to rate human movement control performance in several contexts. In the medical field, for example, smoothness, a feature related to the regularity of movement, is assessed through objective metrics during the execution of free movements in order to support the decision based on clinical scales about the impairment severity. Nevertheless, individuals with and without impairment interact daily with machines to improve their well-being in many contexts: rehabilitation, collaborative robotics, and sport exercises, among others. During these activities, they perform movements in a closed-chain, where inertial or resistance forces introduced by an external tool could affect their motion control. In this study, closed-chain movements performed by three able-bodied and five individuals with coordination impairments were investigated; three different smoothness metrics presented in the literature were applied to analyze the results. The experimental tests consisted in moving a slider mounted on a linear rail with varying velocity and resistance force conditions. Position in the main direction, accelerations and forces in all directions were recorded during the tests. All the metrics detected a smoothness improvement when velocity increased, while only two metrics found an influence of the resistance force on the smoothness.
Unilateral diaphragm dysfunction (UDD) is an important underdiagnosed cause of dyspnea. Inspiratory muscle training (IMT) is the only conservative treatment for UDD, but the clinical utility and mechanisms of improvement are unknown. We characterized the effects of IMT on respiratory muscle function, activity-related dyspnea, and exercise tolerance in people with UDD. 15 people (73% male, 61±8yrs) were randomized to a 6-month IMT (45±6% of maximal inspiratory mouth pressure (PI,max), n=10) or sham program (6±2% PI,max, n=5) consisting of 30 breaths against an external load twice daily. UDD was confirmed by magnetic phrenic nerve stimulation and persisted throughout the intervention. PI,max was measured using a mouth pressure device and maximal transdiaphragmatic pressure during a sniff manuever (Pdi,sniff) with a dual-balloon esophageal catheter. Change in dyspnea was captured by the Transitional Dyspnea Index (TDI) and exercise tolerance by constant load cycle tests performed pre- and post-training. The IMT group completed an average of 330 sessions (92% prescribed) and progressed to 62±23% PI,max. The sham group completed an average of 310 sessions (86%) without progression. PI,max and Pdi,sniff improved more with IMT vs. sham (p=0.003 and p=0.046, respectively). Improvements in TDI score and cycle endurance time were also greater with IMT vs. sham (p=0.008 and p=0.04, respectively). IMT yielded meaningful improvements in respiratory muscle function, dyspnea, and exercise tolerance in people with UDD. The benefits were not related to improvement in isolated diaphragm function, but may reflect increased strength and/or better coorindation of the extra-diaphragmatic inspiratory muscles.
Objective. Rheumatic Heart Disease (RHD) is one of the highly prevalent heart diseases in developing countries that can affect the pericardium, myocardium, or endocardium. Rheumatic endocarditis is a common RHD variant that gradually deteriorates the normal function of the heart valves. RHD can be diagnosed using standard echocardiography or listened to as a heart murmur using a stethoscope. The electrocardiogram (ECG), on the other hand, is critical in the study and identification of heart rhythms and abnormalities. The effectiveness of ECG to identify distinguishing signs of rheumatic heart problems, however, has not been adequately examined. This study addressed the possible use of ECG recordings for the characterization of problems of the heart in RHD patients.Approach. To this end, an extensive ECG dataset was collected from patients suffering from RHD (PwRHD), and healthy control subjects (HC). Bandpass filtering was used at the preprocessing stage. Each data was then standardized by removing its mean and dividing by its standard deviation. Delineation of the onsets and offsets of waves was performed using KIT-IBT open ECG MATLAB toolbox. PR interval, QRS duration, RR intervals, QT intervals, and QTc intervals were computed for each heartbeat. The median values of the temporal parameters were used to eliminate possible outliers due to missed ECG waves. The data were clustered in different age groups and sex. Another categorization was done based on the time duration since the first RHD diagnosis.Main results. In 47.2% of the cases, a PR elongation was observed, and in 26.4% of the cases, the QRS duration was elongated. QTc was elongated in 44.3% of the cases. It was also observed that 62.2% of the cases had bradycardia.Significance. The end product of this research can lead to new medical devices and services that can screen RHD based on ECG which could somehow assist in the detection and diagnosis of the disease in low-resource settings and alleviate the burden of the disease.
Background:Drug-eluting stents (DESs) based on biodegradable polymers (BPs) have been introduced to reduce the risk for late and very late stent thrombosis (ST), which were frequently observed with earlier generations of DES designs based on durable polymers (DPs); however, randomized controlled trials on these DES designs are scarce. The meriT-V trial is a randomized, active-controlled, non-inferiority trial with a prospective, multicenter design that evaluated the 2-year efficacy of a novel third-generation, ultra-thin strut, BP-based BioMime sirolimus-eluting stent (SES) versus the DP-based XIENCE everolimus-eluting stent (EES) for the treatment of de novo lesions.Methods:The meriT-V is a randomized trial that enrolled 256 patients at 15 centers across Europe and Brazil. Here, we report the outcomes of the extended follow-up period of 2 years. The randomization of enrolled patients was in a 2:1 ratio; the enrolled patients received either the BioMime SES (n = 170) or the XIENCE EES (n = 86). The three-point major adverse cardiac event (MACE), defined as a composite of cardiac death, myocardial infarction (MI), or ischemia-driven target vessel revascularization (ID-TVR), was considered as the composite safety and efficacy endpoint. Ischemia-driven target lesion revascularization (ID-TLR) was evaluated as well as the frequency of definite/probable ST, based on the first Academic Research Consortium definitions.Results:The trial had a 2-year follow-up completion rate of 98.44% (n = 252/256 patients), and the clinical outcomes assessment showed a nonsignificant difference in the cumulative rate of three-point MACE between both arms (BioMime vs. XIENCE: 7.74% vs. 9.52%, P = 0.62). Even the MI incidences in the BioMime arm were insignificantly lower than those of the XIENCE arm (1.79% vs. 5.95%, P = 0.17). Late ST was observed in 1.19% cases of the XIENCE arm, while there were no such cases in the BioMime arm (P = 0.16).Conclusions:The objective comparisons between the novel BP-based BioMime SES and the well-established DP-based XIENCE EES in this randomized controlled trial show acceptable outcomes of both the devices in the cardiac deaths, MI, ID-TVR, and ST. Moreover, since there were no incidences of cardiac death in the entire study sample over the course of 2 years, we contend that the findings of the study are highly significant for both these DES designs. In this preliminary comparative trial, the device safety of BioMime SES can be affirmed to be acceptable, considering the lower three-point MACE rate and absence of late ST in the BioMime arm over the 2-year period.
Aims The five-item PRECISE-DAPT, integrating age, haemoglobin, white-blood-cell count, creatinine clearance, and prior bleeding, predicts bleeding risk in patients on dual antiplatelet therapy (DAPT) after stent implantation. We sought to assess whether the bleeding risk prediction offered by the PRECISE-DAPT remains valid among patients receiving ticagrelor monotherapy from 1 month onwards after coronary stenting instead of standard DAPT and having or not having centrally adjudicated bleeding endpoints. Methods and results The PRECISE-DAPT was calculated in 14 928 and 7134 patients from GLOBAL LEADERS and GLASSY trials, respectively. The ability of the score to predict Bleeding Academic Research Consortium 3 or 5 bleeding was assessed and compared among patients on ticagrelor monotherapy (experimental strategy) or standard DAPT (reference strategy) from 1 month after drug-eluting stent implantation. Bleeding endpoints were investigatorreported or centrally adjudicated in GLOBAL LEADERS and GLASSY, respectively. At 2 years, the c-indexes for the score among patients treated with the experimental or reference strategy were 0.67 [95% confidence interval (CI): 0.63-0.71] vs. 0.63 (95% CI: 0.59-0.67) in GLOBAL LEADERS (P = 0.27), and 0.67 (95% CI: 0.61-0.73) vs. 0.66 (95% CI: 0.61-0.72) in GLASSY (P = 0.88). Decision curve analysis showed net benefit using the PRECISEDAPT to guide bleeding risk assessment under both treatment strategies. Results were consistent between investigator-reported and adjudicated endpoints and using the simplified four-item PRECISE-DAPT. Conclusion The PRECISE-DAPT offers a prediction model that proved similarly effective to predict clinically relevant bleeding among patients on ticagrelor monotherapy from 1 month after coronary stenting compared with standard DAPT and appears to be unaffected by the presence or absence of adjudicated bleeding endpoints.